Traditional Chinese medicine composition for treating idiopathic podocytosis and pharmaceutical preparation and application thereof

By combining the theory of Xuanfu in traditional Chinese medicine, traditional Chinese medicine compositions such as raw ephedra, raw gypsum, and raw astragalus are used to regulate the "Xuanfu opening" and "Xuanfu closing", the problems of poor efficacy and obvious side effects of the treatment of idiopathic podocyte disease are solved, and effective reduction of proteinuria and increased serum albumin are achieved, and there is a good clinical application prospect.

CN120131889APending Publication Date: 2025-06-13YUEYANG INTEGRATED TRADITIONAL CHINESE & WESTERN MEDICINE HOSPITAL SHANGHAI UNIV OF CHINESE TRADITIONAL MEDICINE
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Patent Information

Application Number
CN202510144624.9
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-02-10
Publication Date
2025-06-13

AI Technical Summary

Technical Problem

The treatment of idiopathic podocyte disease has problems such as poor efficacy, obvious side effects, expensive price, and frequent recurrences. Some patients are not suitable or cannot tolerate immunosuppressive treatment, resulting in a lack of safe and effective treatment plans.

Method used

Based on the Xuanfu theory of traditional Chinese medicine, the treatment principle of opening Xuanfu and replenishing Qi and solidifying the absorption is proposed. Traditional Chinese medicine compositions such as raw ephedra, raw gypsum, and raw astragalus are used to treat idiopathic podocyte diseases by adjusting the "opening of Xuanfu" and "closing of Xuanfu".

Benefits of technology

This traditional Chinese medicine composition can effectively reduce proteinuria and increase serum albumin, have good clinical efficacy and good safety, and is suitable for long-term use, with few side effects.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention relates to the field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating idiopathic podocytosis, which is prepared from the following raw material medicines in parts by weight: 6 to 12 parts of raw herba ephedrae, 15 to 30 parts of gypsum, 15 to 30 parts of raw radix astragali seu hedysari, 10 to 30 parts of roasted rhizoma atractylodis macrocephalae, 10 to 30 parts of poria cocos, 10 to 30 parts of radix codonopsis, 10 to 15 parts of radix stephaniae tetrandrae, 5 to 15 parts of fresh ginger, 10 to 20 parts of fructus ziziphi jujubae and 5 to 10 parts of liquorice root. Aiming at the symptoms and pathogenesis of the idiopathic podocytosis, the traditional Chinese medicine adopts the treatment principle of opening the Xuanfu, tonifying qi and astringing, is low in raw material cost, simple and convenient to prepare, convenient to use and small in side effect, can be taken for a long time, and has better clinical curative effect and application prospect on the idiopathic podocytosis through clinical application, observation and analysis for many years.
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Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and in particular, to a traditional Chinese medicine composition for treating idiopathic podocytopathy, its pharmaceutical preparation and application. Background Art

[0002] Idiopathic podocytopathy is a type of chronic glomerular disease characterized by pathological changes such as a decrease in the number or density of glomerular podocytes, thickening of the basement membrane, and fusion of foot processes. Clinically, it is mainly manifested as proteinuria and was first proposed by Pollak. It covers various pathological types in clinic, such as minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), membranous nephropathy (MN), etc. In particular, MCD has become the representative of idiopathic podocytopathy. In recent years, the incidence of the above-mentioned idiopathic podocytopathy has shown an obvious upward trend globally, and it is currently the primary glomerular disease with the highest incidence and the fastest growth rate in the world. For example, the incidence of childhood MCD is (15 - 50) / 100,000 per year, accounting for 70% - 90% of primary nephrotic syndrome. The incidence of MN is increasing at a rate of 13% per year, and there is an obvious trend of getting younger.

[0003] Podocytes are the visceral epithelial cells of the glomerulus, which are composed of cell bodies, main processes and foot processes, and are named because their cytoplasm forms pseudopod-like protrusions on the surface of the basement membrane. Podocytes maintain the glomerular filtration function by synthesizing basement membrane components, forming slit diaphragms and promoting the generation of endothelial cells. Under the action of factors such as infection, drugs, and mechanical stretching, the dynamic balance of podocyte adaptation is disrupted, leading to the loss of cell integrity and cell metabolic disorders. Furthermore, pathological changes such as the disappearance of foot process fusion, podocyte shedding or death occur. Under these pathological changes, the pore size of the podocyte slit diaphragm increases or breaks, and the glomerular filtration barrier is damaged, ultimately leading to the occurrence of proteinuria, hypoproteinemia, and edema. Research has shown that drugs for treating idiopathic podocytopathy, including cyclosporine, tripterygium wilfordii, etc., all play a role in reducing podocyte damage and promoting their repair by stabilizing the podocyte cytoskeleton structure, and ultimately achieve the purpose of reducing proteinuria. It can be seen that repairing damaged podocytes is the key to treating idiopathic podocytopathy.

[0004] At present, the treatment of idiopathic podocytopathy is mainly based on hormones and immunosuppressants, including glucocorticoids, cyclosporine, cyclophosphamide, rituximab, etc., but there are problems such as poor efficacy, obvious side effects, high prices, and frequent recurrences. In addition, in clinical practice, some patients are not suitable for immunosuppressive treatment, or have contraindications to the use of immunosuppressants, or relapse after use, or have serious side effects, or refuse to use them, resulting in these patients being in a state of "no drug to cure". This series of problems not only increases the difficulty of clinical treatment, but also accelerates the occurrence of end-stage renal disease, making idiopathic podocytopathy lack a safe and effective treatment plan, and has become a recognized refractory kidney disease. Therefore, strengthening the clinical research of idiopathic podocytopathy has become one of the issues of concern in the field of nephrology.

[0005] There is no report on the Chinese medicine composition for treating idiopathic podocytosis. Summary of the invention

[0006] The purpose of the present invention is to provide a Chinese medicine composition for treating idiopathic podocytosis which has little side effects and can be taken for a long time, as well as a pharmaceutical preparation and application thereof.

[0007] Starting from the "Xuanfu" theory, the present invention combines the structure and functional characteristics of podocytes and proposes that "Xuanfu Kaihe Shi" (opening and closing too much and opening and closing not enough) is an important pathogenesis of idiopathic podocyte disease. Idiopathic podocyte disease belongs to the category of edema in traditional Chinese medicine. The research group of the present invention has been engaged in the clinical treatment and basic research of idiopathic podocyte disease for a long time. Combined with the structure and functional characteristics of podocytes, it is believed that it is consistent with the "Xuanfu theory" of traditional Chinese medicine. "Suwen·Shuirexuelun Pian": "The so-called Xuanfu is the sweat hole." During the Jin and Yuan Dynasties, Liu Wansu believed that Xuanfu was not only a sweat pore, but also an ultra-fine structure of the four cloths of the human body. In modern research on Xuanfu theory, it is often referred to as a microscopic structure distributed throughout the human body. The present invention found that podocytes and Xuanfu have common connotations in terms of position, morphology, characteristics, physiology, etc., especially the pathological changes of foot process fusion and disappearance are very similar to the process of Xuanfu Kaihe Shi in traditional Chinese medicine. Foot process fusion is a process in which the intertwined foot process network of podocytes is simplified, the foot process morphology is changed, and the cross-sectional fissure is reduced or enlarged (the thickening of the foot process causes the fissure to be reduced, while the shortening of the foot process causes the fissure to be enlarged), which further causes the podocyte to fall off and die, and the glomerular filtration barrier is destroyed, resulting in the leakage of albumin and the formation of proteinuria. The opening and closing of Xuanfu includes excessive opening and closing and insufficient opening and closing. Excessive opening and closing of Xuanfu causes the leakage of essence and fine substances, resulting in edema; insufficient opening and closing of Xuanfu leads to occlusion of Xuanfu, causing obstruction of the entry and exit of essence and fine substances such as qi and blood, and the accumulation of body fluids causes edema. The two have similarities from structure to function. Therefore, it is proposed that the opening and closing of Xuanfu (excessive opening and closing and insufficient opening and closing) is an important pathogenesis of podocyte damage and an important link leading to idiopathic podocyte disease. Therefore, based on the pathogenesis of "the opening and closing of Xuanfu is ineffective", the present invention proposes the method of opening Xuanfu and replenishing qi and consolidating qi to treat idiopathic podocyte disease.

[0008] In the first aspect of the present invention, there is provided a traditional Chinese medicine composition for treating idiopathic podocytopathy, which is composed of raw medicinal materials in the following parts by weight: 6-12 parts of raw Ephedra, 15-30 parts of raw Gypsum Fibrosum, 15-30 parts of raw Astragalus membranaceus, 10-30 parts of stir-fried Atractylodes macrocephala, 10-30 parts of Poria cocos, 10-30 parts of Codonopsis pilosula, 10-15 parts of Stephania tetrandra, 5-15 parts of fresh Ginger, 10-20 parts of Chinese Date, and 5-10 parts of Licorice Root.

[0009] Further, the traditional Chinese medicine composition is composed of raw medicinal materials in the following parts by weight: 9 parts of raw Ephedra, 24 parts of raw Gypsum Fibrosum, 30 parts of raw Astragalus membranaceus, 15 parts of stir-fried Atractylodes macrocephala, 15 parts of Poria cocos, 15 parts of Codonopsis pilosula, 12 parts of Stephania tetrandra, 9 parts of fresh Ginger, 10 parts of Chinese Date, and 6 parts of Licorice Root.

[0010] In the second aspect of the present invention, there is provided a pharmaceutical preparation using the above-mentioned traditional Chinese medicine composition as an active ingredient, and the pharmaceutical preparation is prepared into a commonly used pharmaceutical dosage form by a conventional preparation method in the art.

[0011] Further, the dosage form of the pharmaceutical preparation is decoction, tablet, capsule, granule, pill, oral liquid or syrup.

[0012] Further, the pharmaceutical preparation also includes pharmaceutically acceptable excipients.

[0013] In the third aspect of the present invention, there is provided an application of the above-mentioned traditional Chinese medicine composition in the preparation of a drug for treating idiopathic podocytopathy.

[0014] In the fourth aspect of the present invention, there is provided an application of the above-mentioned pharmaceutical preparation in the preparation of a drug for treating idiopathic podocytopathy.

[0015] The traditional Chinese medicine composition compound of the present invention is formulated by carefully selecting herbs and forming a prescription under the guidance of traditional Chinese medicine theory based on years of clinical practice. It can regulate both the "opening of the mysterious cavity" and the "closing of the mysterious cavity". In the prescription, Ephedra is pungent, warm and dispersing, walking on the surface; Gypsum is pungent, cold and can penetrate the surface and clear interior heat. When the two herbs are used together, the two pungent herbs combine, one dispersing and one spreading, with cold and warm offsetting each other. There is no worry about Ephedra promoting heat and generating fire, nor the drawback of Gypsum being heavy, cold and cool. It harmonizes yin and yang. The compatibility of Ephedra and Gypsum makes them the monarch herbs together to open the mysterious cavity, that is, to regulate the "opening of the mysterious cavity", doubling the power of pungent opening and dispersing. The lung is dredged and descended, the water qi is dispersed externally and transported downward to the bladder, and the edema is eliminated. Astragalus membranaceus is slightly warm in nature, sweet in taste, and belongs to the spleen and lung meridians, with the functions of tonifying qi and strengthening the superficial resistance, promoting diuresis and reducing edema; Atractylodes macrocephala is warm in nature, bitter and sweet in taste, and belongs to the spleen and stomach meridians, with the effect of tonifying qi and strengthening the spleen; Poria cocos is neutral in nature, sweet in taste, and belongs to the heart, spleen, kidney and lung meridians, with the effect of strengthening the spleen, promoting diuresis and percolating dampness; Codonopsis pilosula is neutral in nature, sweet in taste, and belongs to the spleen and lung meridians, with the effect of tonifying qi and strengthening the spleen. Astragalus membranaceus, Poria cocos, Atractylodes macrocephala and Codonopsis pilosula are the ministerial herbs together to tonify qi and astringe, that is, to regulate the "closing of the mysterious cavity". Stephania tetrandra is bitter and cold in nature, with the effects of clearing heat and promoting diuresis, dispelling wind and relieving pain; Ginger is pungent in taste, slightly warm in nature, and belongs to the lung, spleen and stomach meridians, with the effects of inducing sweating to dispel cold, warming the middle-jiao and stopping vomiting; Jujube is warm in nature, sweet in taste, and belongs to the spleen and stomach meridians, with the effects of replenishing qi to the middle-jiao, nourishing blood and calming the mind. Stephania tetrandra, Ginger and Jujube are the assistant herbs together. Licorice is sweet in taste, neutral in nature, and belongs to the heart, lung, spleen and stomach meridians. It can clear heat and detoxify, and harmonize all the herbs, serving as the guiding herb. The combination of all the herbs plays the role of opening the mysterious cavity and tonifying qi and astringing, corresponding to the core pathogenesis of idiopathic podocytopathy.

[0016] The advantages and beneficial effects of the present invention are as follows:

[0017] Aiming at the symptoms and pathogenesis of idiopathic podocytopathy, the present invention adopts the treatment principle of opening the mysterious cavity and tonifying qi and astringing. The raw materials used are inexpensive, the preparation is simple, the use is convenient, the side effects are small, and it can be taken for a long time. After years of clinical application, observation and analysis, it has good clinical curative effects on idiopathic podocytopathy. Given that the number of patients with idiopathic podocytopathy is large, bringing great physical and mental pain to the patients, and the current hormone and immunosuppressive therapies have poor treatment effects, with problems such as hormone resistance, hormone dependence, frequent recurrence, and obvious side effects, the traditional Chinese medicine composition provided by the present invention has good application prospects. Specific Embodiments

[0018] The following details the specific embodiments provided by the present invention in conjunction with the examples. For the experimental methods without specific conditions noted in the following examples, they are usually in accordance with conventional conditions or the conditions recommended by the manufacturers. The medicinal materials used in the embodiments of the present invention can be obtained from Chinese medicinal materials sales companies unless otherwise noted. The obtained medicinal materials are Chinese medicinal herbal pieces unless otherwise noted. The herbal pieces can be obtained from the sales company or processed after obtaining.

[0019] Example 1: The traditional Chinese medicine composition of the present invention

[0020] 6 parts of raw Ephedrae Herba, 15 parts of raw Gypsum Fibrosum, 20 parts of raw Astragali Radix, 10 parts of stir-fried Atractylodis Macrocephalae Rhizoma, 10 parts of Poria, 10 parts of Codonopsis Pilosulae Radix, 10 parts of Stephaniae Tetrandrae Radix, 5 parts of fresh Ginger Rhizome, 12 parts of Jujube Fruit, 5 parts of Licorice Root.

[0021] Example 2: The traditional Chinese medicine composition of the present invention

[0022] 8 parts of raw Ephedrae Herba, 20 parts of raw Gypsum Fibrosum, 25 parts of raw Astragali Radix, 20 parts of stir-fried Atractylodis Macrocephalae Rhizoma, 20 parts of Poria, 20 parts of Codonopsis Pilosulae Radix, 14 parts of Stephaniae Tetrandrae Radix, 8 parts of fresh Ginger Rhizome, 15 parts of Jujube Fruit, 8 parts of Licorice Root.

[0023] Example 3: The traditional Chinese medicine composition of the present invention

[0024] 9 parts of raw Ephedrae Herba, 24 parts of raw Gypsum Fibrosum, 30 parts of raw Astragali Radix, 15 parts of stir-fried Atractylodis Macrocephalae Rhizoma, 15 parts of Poria, 15 parts of Codonopsis Pilosulae Radix, 12 parts of Stephaniae Tetrandrae Radix, 9 parts of fresh Ginger Rhizome, 10 parts of Jujube Fruit, 6 parts of Licorice Root.

[0025] Example 4: The traditional Chinese medicine composition of the present invention

[0026] 10 parts of raw Ephedrae Herba, 25 parts of raw Gypsum Fibrosum, 30 parts of raw Astragali Radix, 25 parts of stir-fried Atractylodis Macrocephalae Rhizoma, 25 parts of Poria, 25 parts of Codonopsis Pilosulae Radix, 13 parts of Stephaniae Tetrandrae Radix, 10 parts of fresh Ginger Rhizome, 18 parts of Jujube Fruit, 9 parts of Licorice Root.

[0027] Example 5: The traditional Chinese medicine composition of the present invention

[0028] 12 parts of raw Ephedrae Herba, 30 parts of raw Gypsum Fibrosum, 15 parts of raw Astragali Radix, 30 parts of stir-fried Atractylodis Macrocephalae Rhizoma, 30 parts of Poria, 30 parts of Codonopsis Pilosulae Radix, 15 parts of Stephaniae Tetrandrae Radix, 15 parts of fresh Ginger Rhizome, 20 parts of Jujube Fruit, 10 parts of Licorice Root.

[0029] Example 6: Preparation of the decoction of the traditional Chinese medicine composition of the present invention

[0030] Adopt the conventional method for making traditional Chinese medicine decoction, that is, weigh any one of the traditional Chinese medicine compositions in Examples 1-5, add water and decoct into a decoction.

[0031] Example 7: Preparation of the tablets / capsules of the traditional Chinese medicine composition of the present invention

[0032] Weigh any one of the traditional Chinese medicine compositions in Examples 1-5, grind it finely, decoct it, concentrate it under reduced pressure to obtain an extract, dry and crush the extract to make granules, add pharmaceutical adjuvants, and press into tablets or fill into capsules.

[0033] Example 8: Preparation of the granules of the traditional Chinese medicine composition of the present invention

[0034] Weigh any one of the traditional Chinese medicine compositions in Examples 1-5, grind it finely, decoct it, concentrate it under reduced pressure to obtain an extract, dry and crush the extract to make granules.

[0035] Example 9: Preparation of the traditional Chinese medicine composition pills / oral liquid / syrup of the present invention

[0036] Weigh any one of the traditional Chinese medicine compositions described in Examples 1-5, grind it finely, decoct it, take the supernatant, and concentrate it to a thick extract; add appropriate pharmaceutical excipients (such as white sugar, honey, benzoic acid or ethylparaben, etc.) to make pills, oral liquid or syrup.

[0037] Example 10: Pharmacodynamic experiment (clinical trial) of the traditional Chinese medicine composition of the present invention

[0038] (I) Source of cases: 60 patients with idiopathic podocytopathy who visited the nephrology ward or outpatient clinic of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine from January 2021 to December 2023 were collected. All patients gave informed consent, and this study has been registered with the Chinese Clinical Trial Registry (Registration number: ChiCTR2400087035).

[0039] (II) Inclusion criteria: (1) The pathological type of renal biopsy is primary minimal change disease (MCD), primary focal segmental glomerulosclerosis (FSGS) and primary membranous nephropathy (MN); (2) The clinical manifestations are proteinuria, which may be combined with hematuria, edema, hypertension, and renal insufficiency; (3) Glomerular filtration rate > 30 ml / min·1.73m 2 (calculated according to the EPI formula); (4) 24-hour urinary protein quantification ≥ 1.0 g and < 3.5 g; (5) Aged between 18 and 70 years old; (6) Patients who have signed the informed consent form.

[0040] (III) Exclusion criteria: (1) Those who do not meet the above inclusion criteria; (2) Patients with stage 4 and stage 5 chronic kidney disease and renal replacement therapy; (3) Patients with secondary nephropathy; (4) Patients with contraindications to ACEI / ARB, including renal artery stenosis, hyperkalemia, solitary kidney, etc.; (5) Patients complicated with severe infection, malnutrition, and acute renal failure; (6) Patients with severe impairment of heart, liver, and brain functions or other serious underlying diseases; (7) Those known to be allergic to the components of the traditional Chinese medicine granules used; (8) Pregnant or lactating women; (9) Patients with severe mental illness; (10) Those who are undergoing other clinical trial studies.

[0041] (IV) Research methods:

[0042] 1. Baseline data: 60 patients were divided into 2 groups according to the random number table method. There were 30 patients in the treatment group, including 17 males and 13 females; the age ranged from 31 to 65 years old, with an average of (45.41 ± 10.96) years; the disease course was 3 to 12 months, with an average of (7.52 ± 3.28) months. There were 30 patients in the control group, including 20 males and 10 females; the age ranged from 28 to 58 years old, with an average of (43.20 ± 10.75) years; the disease course was 2 to 10 months, with an average of (6.97 ± 3.66) months. There was no statistically significant difference in the general data between the two groups (P > 0.05), and they were comparable.

[0043] 2. Medication method: The control group adopted conventional non-immunosuppressive treatment, including valsartan capsules (Huaren Saike Pharmaceutical Co., Ltd., 80 mg / tablet, national drug approval number H20030638), once a day, one tablet each time; dapagliflozin tablets (AstraZeneca Pharmaceutical Co., Ltd., 10 mg / tablet, production batch number H20170206), once a day, one tablet each time. At the same time, a high-quality protein diet was adopted, with appropriate rest, avoiding infection, and maintaining blood pressure at 120 - 135 / 75 - 85 mmHg. The treatment group added a traditional Chinese medicine composition on the basis of the control group: orally take the decoction made from 9g of raw Ephedra, 24g of raw Gypsum, 30g of raw Astragalus membranaceus, 15g of stir-fried Atractylodes macrocephala, 15g of Poria cocos, 15g of Codonopsis pilosula, 12g of Stephania tetrandra, 9g of fresh Ginger, 10g of Chinese date, and 6g of Licorice root, one dose per day, warm taken in two divided doses in the morning and evening. The treatment course for both groups was 24 weeks.

[0044] (V) Observation indicators:

[0045] Observe the clinical efficacy of the two groups; compare the changes in 24-hour urinary protein quantification (24h UTP), serum albumin (ALB), and estimated glomerular filtration rate (eGFR) before and after treatment in the two groups; compare the changes in the excretion amounts of urinary podocyte injury marker proteins (Nephrin, Podocin) before and after treatment in the two groups; observe the changes in safety indicators such as blood routine, liver function, electrolytes, electrocardiogram, and fecal routine before and after treatment in the two groups.

[0046] (VI) Efficacy judgment criteria:

[0047] Refer to the "Clinical Practice Guidelines for Kidney Diseases" to judge the clinical efficacy of the two groups of patients: Complete remission: 24h UTP < 0.3g, and renal function is stable; Partial remission: 24h UTP decreases by more than or equal to 50% of the baseline value, but does not reach complete remission, and eGFR decreases within 10% of the baseline value; Ineffective: 24h UTP decreases by less than 50% of the baseline value, eGFR decreases by more than 50% of the baseline value or enters end-stage renal disease (ESRD). The total effective rate = (complete remission + partial remission) / total number of cases × 100%.

[0048] (VII) Data analysis:

[0049] The data were analyzed using SPSS 24.0 statistical software. Measurement data conforming to the normal distribution were expressed as mean ± standard deviation ( ), and the t-test was used; for measurement data not conforming to the normal distribution, the rank sum test was used. The comparison of count data was performed using test. A P < 0.05 was considered statistically significant.

[0050] (VIII) Results:

[0051] 1. Case exclusion, dropout, or termination

[0052] During the treatment process, 1 case in the treatment group withdrew from the trial due to personal reasons and failed to undergo laboratory tests on time, and 2 cases in the control group withdrew from the trial due to receiving immunotherapy. Finally, 29 cases were included in the treatment group and 28 cases were included in the control group.

[0053] 2. Comparison of clinical efficacy

[0054] The total effective rate of the treatment group was 75.9% (22 / 29), and the total effective rate of the control group was 57.1% (16 / 28). The total effective rate of the treatment group was higher than that of the control group (P < 0.05). See Table 1.

[0055] Table 1 Comparison of clinical efficacy of 2 groups of patients (cases)

[0056]

[0057] Compared with the control group, * P < 0.05.

[0058] 3. Comparison of 24h UTP, ALB, and eGFR before and after treatment

[0059] Compared with before treatment in the same group, 24h UTP decreased in both groups after treatment (P < 0.05), the ALB level increased in both groups (P < 0.05), and the improvement of 24h UTP and ALB levels after treatment in the treatment group was better than that in the control group (P < 0.05). There was no significant change in the eGFR level in both groups before and after treatment (P > 0.05). See Table 2.

[0060] Table 2 Comparison of changes in 24h UTP, ALB, and eGFR levels before and after treatment in 2 groups ( )

[0061]

[0062] Compared with before treatment in the same group, * P < 0.05; compared with after treatment in the control group, △ P < 0.05.

[0063] 4. Comparison of urinary podocyte injury marker proteins before and after treatment

[0064] Compared with before treatment in this group, the levels of urinary Nephrin and Podocin in both groups decreased after treatment (P < 0.05), and the levels of urinary Nephrin and Podocin in the treatment group were lower than those in the control group after treatment (P < 0.05). See Table 3.

[0065] Table 3 Comparison of changes in the levels of urinary podocyte injury marker proteins before and after treatment in two groups ( )

[0066]

[0067] Compared with before treatment in this group, * P < 0.05; compared with after treatment in the control group, △ P < 0.05.

[0068] 5. Comparison of safety indicators

[0069] Before and after treatment, there were no abnormal changes in safety indicators such as blood routine, liver function, electrolytes, electrocardiogram, and fecal routine in both groups of patients (P > 0.05), and no adverse reactions occurred.

[0070] Clinical efficacy observation shows that the traditional Chinese medicine composition of the present invention has a definite clinical efficacy in the treatment of idiopathic podocytopathy, can effectively reduce proteinuria in patients, increase serum albumin, has good efficacy and safety, and its mechanism of action may be closely related to reducing the levels of urinary Nephrin and Podocin and improving podocyte injury.

[0071] The preferred embodiments of the present invention have been specifically described above, but the present invention is not limited to the described embodiments. Those skilled in the art can also make various equivalent variations or substitutions without departing from the spirit of the present invention, and these equivalent variations or substitutions are all included in the scope defined by the claims of this application.

Claims

1. A Chinese medicine composition for treating idiopathic podocyte disease, characterized in that: The invention is composed of the following raw materials in parts by weight: 6-12 parts of raw ephedra, 15-30 parts of raw gypsum, 15-30 parts of raw astragalus, 10-30 parts of stir-fried atractylodes, 10-30 parts of tuckahoe, 10-30 parts of codonopsis pilosula, 10-15 parts of tetrandra, 5-15 parts of ginger, 10-20 parts of jujube and 5-10 parts of liquorice.

2. The Chinese medicine composition according to claim 1, characterized in that: The drug composition is composed of the following raw materials in parts by weight: 9 parts of raw ephedra, 24 parts of raw gypsum, 30 parts of raw astragalus, 15 parts of stir-fried atractylodes, 15 parts of tuckahoe, 15 parts of codonopsis, 12 parts of stephania tetrandra, 9 parts of ginger, 10 parts of jujube and 6 parts of liquorice.

3. A pharmaceutical preparation using the Chinese medicine composition as claimed in claim 1 or 2 as an active ingredient, characterized in that: The pharmaceutical preparation is prepared into a common dosage form in pharmacy by conventional preparation methods in the art.

4. The pharmaceutical preparation according to claim 3, characterized in that The dosage form of the pharmaceutical preparation is decoction, tablet, capsule, granule, pill, oral liquid or syrup.

5. The pharmaceutical preparation according to claim 4, characterized in that The pharmaceutical preparation also includes pharmaceutically acceptable excipients.

6. Use of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a medicament for treating idiopathic podocytosis.

7. Use of the pharmaceutical preparation according to any one of claims 3 to 5 in the preparation of a drug for treating idiopathic podocytosis.